| Primary Device ID | 00643169887633 |
| NIH Device Record Key | d4275250-267b-494c-91a4-1c16657e1ea0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8578 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169887633 [Primary] |
| LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-07-08 |
| 20763000825380 - NA | 2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG |
| 20763000984193 - NA | 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG |
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |